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Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit

Effect of in Situ Simulation on Quality of Work Life and Multiprofessional Team Effectiveness in the Intensive Care Unit

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06944821
Acronym
EFFIQUASS
Enrollment
90
Registered
2025-04-25
Start date
2025-05-19
Completion date
2026-04-17
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn-out, Quality of Work Life, Simulation

Keywords

In-situ simulation, Intensive care, Stress, Quality of working life, Quality of care, Performance, Caregivers, Teamwork

Brief summary

The lack of specific, personalized training for intensive care workers can lead to a deterioration in quality of life at work, and can result in burnout, absenteeism or wanting to leave the service. The aim of this study is to assess the impact of in situ simulation on quality of work life and the effectiveness of multi-professional teamwork in intensive care.

Detailed description

Paramedics in intensive care are particularly exposed to the risk of burnout, which is multifactorial (psychologically and physically challenging environment, life-threatening emergency context, etc.). Personal assistance professions require a high level of compassion, leading to a positive feeling of compassionate satisfaction, i.e. the satisfaction of helping others. Compassion fatigue leads to a reduction in job satisfaction, culminating in burnout. Factors negatively influencing compassion satisfaction are the absence of specific and adapted training, or the lack of support from the hierarchy. Among the pedagogical tools available, in situ simulation could be used to respond to a specific and personalized training request from a care department. The study will be carried out in the cardio-thoracic intensive care unit at Montpellier University Hospital, comparing 2 groups to assess the effect of simulation on paramedics. Paramedics will be randomized into 2 groups, with stratification on diploma (nursing assistant or nurse): group A benefiting from a simulation program, and group B not benefiting from it during the study.

Interventions

Each simulation session takes place over one day, with 4 scenarios recreating life-threatening emergency situations (cardiorespiratory arrest, hemorrhagic shock, etc.). Each scenario is designed to meet specific pedagogical objectives, which will be debriefed by simulation trainers: crisis resource management (communication, alerting, etc.) or organization of multi-professional teamwork

OTHERRole-playing using a simulation scenario

Team performance in critical situations, assessed during a simulation scenario for all participants. The assessment will be carried out blind by 1 examiner, trained in CRM (Crisis Resource Management) analysis in simulation and debriefing.

OTHERQuestionnaires

Quality of lige questionnaire Pro-QOL, Karasek questionnaire, Satisfaction questionnaire at work : WRQoL, Work Life Balance scale, Mayo Hight Team Performance scale will be completed at baseline and at 6 months

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Paramedical staff (nurse and nursing assistant) in the cardiothoracic intensive care unit at Montpellier University Hospital. * Acceptance of being filmed for direct video transcription during the intervention

Exclusion criteria

* Refusal of consent or inability to give consent (guardianship, curatorship) * Paramedics intending to leave the department before the end of the study. * Not affiliated to a French social security scheme or not a beneficiary of such a scheme

Design outcomes

Primary

MeasureTime frameDescription
Subscale of compassion satisfaction of ProQOL-5 (Professional Quality of Life Scale version 5From baseline to the end of the follow up at 6 monthsThe ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Compassion Satisfaction is composed of 10 questions. A score ≤ 22 indicates a deterioration in compassion satisfaction.

Secondary

MeasureTime frameDescription
Burnout subscale of ProQOL-5From baseline to the end of the follow up at 6 monthsThe ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale Burnout is composed of 10 questions. A score ≥42 indicates a hight burnout level
Vicarious trauma subscale of ProQOLFrom baseline to the end of the follow up at 6 monthsThe ProQOL is composed of 30 questions with 3 subscales : compassion satisfaction, burnout and vicarious trauma. Each response are scored from 1 to 5 . The subscale " Vicarious Trauma " is composed of 10 questions. A score ≥42 indicates a hight vicarious trauma level
KarasekFrom baseline to the end of the follow up at 6 monthsThe Karasek self-questionnaire assess the "job strain ". It is composed of 3 susbscales : the psychological demand, the Decision latitude and the Social support at work. A decision-making latitude score \< 72 and a Psychological Demand score ≥ 21 is associated with a Job Strain
WRQoL (QwOL)From baseline to the end of the follow up at 6 monthsThe Work-related Quality of Life is composed of 23 questions. It evaluates 6 dimensions: the feeling of being involved in decisions (3 assertions), appreciation of work organization and general satisfaction (7), help with external demands (3), satisfaction with working conditions (3), satisfaction with the ability to do one's job (6) and stress at work (2). A higher score is associated to a highter quality of life at work.
Work-Life Balance scale questionnaireFrom baseline to the end of the follow up at 6 monthsThe Work-Life Balance scale assess the impact of work on personal quality of life. It is composed of 3 subscales about : Work interferes with personal life (WIPL), Personal interferes with work (PLIW), Satisfaction with quality of personal and work life (WPLE). A high score is associated with significant interference of work with private life
Mayo High Performance Team ScaleFrom baseline to the end of the follow up at 6 monthsThe Mayo High Performance Team Scale is a standardized evaluation scale, designed to meet non-technical teaching objectives named CRM (Crisis Resource Management). This scale assess the effectiveness and performance of teams of emergency care workers
Adverse eventFrom baseline to the end of the follow up at 6 monthsOccurrence of adverse events or errors linked to a lack of interprofessional communication

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026